Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD)

May 3, 2007 updated by: National Institute of Mental Health (NIMH)
A long-term study of current treatments for bipolar disorder, including medications and psychosocial therapies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

STEP-BD is evaluating all the best-practice treatment options used for bipolar disorder: mood-stabilizing medications, antidepressants, atypical antipsychotics, and psychosocial interventions - or "talk" therapies - including Cognitive Behavioral Therapy, Family-focused Therapy, Interpersonal and Social Rhythm Therapy, and Collaborative Care (psychoeducation).

There are two kinds of treatment "pathways" in STEP-BD, and participants may have the opportunity to take part in both. The medications and psychosocial interventions provided in these pathways are considered among the best choices of treatment for bipolar disorder in everyday clinical practice.

In the "Best Practice Pathway," participants are followed by a STEP-BD certified doctor and all treatment choices are individualized. Everyone enrolled in STEP-BD may participate in this pathway. Participants and their doctors work together to decide on the best treatment plans and to change these plans if needed. Also, anyone who wishes to stay on his or her current treatment upon entering STEP-BD may do so in this pathway. Adolescents and adults age 15 years and older may participate in the Best Practice Pathway.

For adults age 18 and older, another way to participate is in the STEP-BD "Randomized Care Pathways." Depending on their symptoms, participants may be offered treatment in one or more of these pathways during the course of the study. The participants remain on mood-stabilizing medication. However, because doctors are uncertain which of several treatment strategies work best for bipolar disorder, another medication and/or talk therapy may be added. Each Randomized Care Pathway involves a different set of these additional treatments.

Unlike in the Best Practice Pathway, the participants in the Randomized Care Pathways are randomly assigned to treatments. Also, in some cases, neither the participant nor the doctor will be told which of the different medications is being added. This is called a "double-blind" study and is done so that the medication effects can be evaluated objectively, without any unintended bias that may come from knowing what has been assigned. Participants will not be assigned medications that they have had bad reactions to in the past, that they are strongly opposed to, or that the doctor feels are unsuitable for them. The medication(s) participants may be randomly assigned to in the Randomized Care Pathways are free of charge. There are other treatment options for participants if they do not respond well to the treatment assigned to them. Also, participants may return to the Best Practice Pathway at any time. About 1,500 individuals will be enrolled in at least one Randomized Care Pathway during their period of participation in STEP-BD.

It is important to note that STEP-BD provides continuity of care. For example, if a participant starts out in the Best Practice Pathway and later chooses to enter one of the Randomized Care Pathways, he or she continues with the same STEP-BD doctor and treatment team. Then, after completing the Randomized Care Pathway, the participant may return to the Best Practice Pathway for ongoing, individually-tailored treatment.

Study Type

Interventional

Enrollment

5000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305-5723
        • Stanford University School of Medicine
    • Colorado
      • Denver, Colorado, United States, 80220
        • University of Colorado, Colorado Psychiatric Health Clinical Investigation Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74135
        • University of Oklahoma Health Sciences Center
    • Oregon
      • Portland, Oregon, United States, 97201
        • Portland Veteran's Administration Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-2649
        • University of Pennsylvania Medical Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • San Antonio, Texas, United States, 78229-3900
        • University of Texas Health Science Center at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

General Inclusion Criteria:

  • current age 15 or older (Best Practice Pathway) or 18 years or older (Randomized Care Pathways);
  • able to give informed consent for data to be harvested;
  • meet DSM-IV criteria for Bipolar I Disorder, Bipolar II Disorder, Bipolar Disorder NOS, or Cyclothymic Disorder;
  • undergo a complete standard evaluation including clinical interview, self ratings, and laboratory studies;
  • meet with Clinical Specialist as scheduled;
  • able to complete all Study Registry Forms within 3 months of registration.

General Exclusion Criteria:

  • unwilling or unable to adhere to basic study requirements (i.e., complete rating forms, or attend scheduled evaluations);
  • not competent to give informed consent in the opinion of the investigator (e.g., psychotic).

Participants will be asked to remain in the study for up to five years so that the investigators can document and evaluate long-term treatment outcome. Participants will meet with their STEP-BD psychiatrist for periodic evaluations and/or treatment adjustments during the course of the study, fill out various self-rating forms, and when applicable, participate in psychotherapy. One of the psychotherapy options, Family-Focused Therapy, will require participants and their families to attend counseling sessions together. Overall, the estimated amount of time required from participants in the study is 2 to 4 hours per month.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Gary Sachs, M.D., Massachusetts General Hospital
  • Principal Investigator: Michael Thase, M.D., University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1998

Study Completion

September 1, 2005

Study Registration Dates

First Submitted

March 13, 2001

First Submitted That Met QC Criteria

March 14, 2001

First Posted (Estimate)

March 15, 2001

Study Record Updates

Last Update Posted (Estimate)

May 4, 2007

Last Update Submitted That Met QC Criteria

May 3, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N01 MH80001
  • DSIR AT (NCT00590863)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bipolar Disorder

Clinical Trials on risperidone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe